Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking approval for its investigational Bruton's tyrosine kinase (BTK) inhibitor, ...

Entering text into the input field will update the search result below Entering text into the input field will update the search result below ...

Charles River Laboratories International, Inc. provides drug discovery, non-clinical development, and safety testing services in the United States, Europe, Canada, the Asia Pacific, and ...

REDWOOD CITY, Calif., December 31, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat ...

A big part of Biogen's efforts to defend its spinal muscular atrophy (SMA) business has been dealt a setback by the FDA, which declined to approve a high-dose version of its flagship Spinraza product.

Investing.com -- Sanofi SA (EPA:SASY) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application of tolebrutinib, which was ...

Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US. The FDA sent the Danish ...

Corcept Therapeutics CORT announced that the FDA has issued a complete response letter (“CRL”) to its new drug application (“NDA”), seeking approval for its proprietary, selective cortisol modulator, ...